Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BYF — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
33 daysmedian FDA review time
89 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955483 | TRACH MASK MODEL (245, 246) | Hospitak, Inc. | 1996-02-28 | 89 | 0 |
| K951652 | VENTIMASK MK IV | Flexicare Medical, Ltd. | 1995-04-27 | 17 | 0 |
| K894457 | CARNATION TRACHEOSTOMY MASKS | Dadsun Corp., Ltd. | 1989-10-13 | 87 | 0 |
| K860873 | VENTURI MASK/ADULT & PAEDIATRIC | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 | 23 | 0 |
| K860874 | VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 | 22 | 0 |
| K852618 | OXY-DIAL | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K832725 | DUAL DIAL VENTURI STYLE MASK | Airlife, Inc. | 1983-09-20 | 39 | 0 |
| K812066 | PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN | Airlife, Inc. | 1981-08-03 | 13 | 0 |
| K810947 | AIR ENTRAINMENT TRACH T | Airlife, Inc. | 1981-06-02 | 56 | 0 |
| K810946 | ADULT & PEDIATRIC TRACHEOSTOMY MASKS | Airlife, Inc. | 1981-06-02 | 56 | 0 |
| K810373 | VENTURI MASK/DELIVERY SYSTEM #'S | Todd Industries, Inc. | 1981-03-17 | 33 | 0 |
| K810430 | VENTURI MASK/DELIVERY SYSTEM #6078 | Todd Industries, Inc. | 1981-03-13 | 22 | 0 |
| K790146 | MASK, PERCENTO | Airlife, Inc. | 1979-02-06 | 25 | 0 |
| K781325 | MARKII VENTIMASKS | Vickers America Medical Corp. | 1978-09-27 | 57 | 0 |
| K780626 | VENTURI OXYGEN MASK | Hospitak, Inc. | 1978-05-26 | 42 | 0 |
| K780011 | CONCHAPAK OXYGEN DILUTER | Respiratory Care, Inc. | 1978-02-02 | 30 | 0 |
| K772127 | OXYGEN MASK, AIR-ENTRAINMENT | Salter Labs | 1978-01-03 | 53 | 1 |
| K771385 | 2 JET SET | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-08-04 | 8 | 0 |
| K760518 | ADAPTER, PER-CEN-TOX-BODY | Landmark Plastics | 1976-09-03 | 8 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda